Eosinophilic Esophagitis
Conditions
Brief summary
This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil). The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.
Interventions
RADIATIONComputerized Tomography scan
imaging scan from a person's eyes to their thighs
RADIATIONSingle Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
DRUGTechnetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
RADIATIONPlanar Images
2 dimensional imaging - whole body planar scans
PROCEDUREEsophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies
Sponsors
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population * 7 controls (subjects without GI symptoms and known GI disease)
Exclusion criteria
* bleeding diathesis or contraindication to esophageal biopsies * severe sleep apnea * incarceration * pregnancy * inability to lie flat for 2 hours * history of bleeding disorder * Use of steroids * Breast feeding * Allergy to heparin or history of severe reaction to heparin * allergy to mucomyst or severe asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of Tc99m-heparin | over approximately 24-26 hours | Biodistribution of Tc99m-heparin to the esophagus and other organs, especially of the gastrointestinal tract as judged by planar scans and by single photon emission computed tomography scans. |
| Calculation of organ doses | over approximately 24-26 hours | Calculation of organ doses from the oral administration of Tc99m-heparin. The organ doses will be measured in miliSieverts using a computer program called OLINDA (Version 2). |
Countries
United States
Outcome results
None listed